Photodynamic bone stabilization systems and methods for reinforcing bone

ABSTRACT

Photodynamic bone stabilization systems are disclosed herein. In an embodiment, a photodynamic bone stabilization system includes a catheter having an elongated shaft with a proximal end adapter, a distal end releasably engaging an expandable portion, and a longitudinal axis therebetween; a light-conducting fiber configured to transmit light energy to the expandable portion; a light-sensitive liquid monomer comprising an initiator, wherein the initiator is activated when the light-conducting fiber transmits the light energy to initiate polymerization of the light-sensitive liquid monomer; and a cooling medium configured to control polymerization temperature, wherein the catheter comprises an inner void sufficiently designed to pass the light-sensitive liquid monomer into the expandable portion, and wherein the catheter comprises an inner lumen sufficiently designed to pass the light-conducting fiber into the expandable portion and configured to circulate the cooling medium.

RELATED APPLICATIONS

This application claims the benefit of and priority to U.S. ProvisionalPatent Application No. 61/167,276, filed on Apr. 7, 2009, the entiretyof this application is hereby incorporated herein by reference.

FIELD

The embodiments disclosed herein relate to minimally invasive orthopedicprocedures, and more particularly to photodynamic bone stabilizationsystems for use in repairing a weakened or fractured bone.

BACKGROUND

Bone fracture repairs are surgical procedures to realign and stabilizebroken bones, and are conventionally carried out using plates, nails,screws or pins. Current methods of treating bone fractures each havesignificant drawbacks. For example, tendon adhesions are typical incasting; soft tissue injury occurs frequently when plates or screws areinserted during open surgery; and K-wires do not provide sufficientsupport for immediate movement. Frequently, these procedures requireextensive post operative recuperation and present with co-morbidities,such as, stiffness and loss of range of motion. For example, postsurgical soft tissue injury can reduce mobility, and callous mayincorporate into surrounding tendons further reducing mobility.

SUMMARY

Photodynamic bone stabilization systems are disclosed herein. Accordingto aspects illustrated herein, a photodynamic bone stabilization systemincludes a catheter having an elongated shaft with a proximal endadapter, a distal end releasably engaging an expandable portion, and alongitudinal axis therebetween; a light-conducting fiber configured totransmit light energy to the expandable portion; a light-sensitiveliquid monomer comprising an initiator, wherein the initiator isactivated when the light-conducting fiber transmits the light energy toinitiate polymerization of the light-sensitive liquid monomer; and acooling medium configured to control polymerization temperature, whereinthe catheter comprises an inner void sufficiently designed to pass thelight-sensitive liquid monomer into the expandable portion, and whereinthe catheter comprises an inner lumen sufficiently designed to pass thelight-conducting fiber into the expandable portion and configured tocirculate the cooling medium.

According to aspects illustrated herein, a photodynamic bonestabilization system includes a light-conducting fiber configured totransmit light energy; a light-sensitive liquid monomer comprising aninitiator, wherein the initiator is activated when the light-conductingfiber transmits the light energy; a pressurizing medium configured tocontrol polymerization shrinkage; and a catheter having an elongatedshaft with a proximal end adapter, a distal end releasably engaging anexpandable portion, and a longitudinal axis therebetween, wherein thecatheter comprises an inner void and an inner lumen, wherein the innervoid is sufficiently designed to pass the light-sensitive liquid monomerinto the expandable portion, wherein the inner lumen is sufficientlydesigned to pass the light-conducting fiber into the expandable portion,and wherein the inner lumen comprises expandable portions configured toexpand when the pressurizing medium is delivered to the inner lumen soas to cause internal diameter pressure against the light-sensitiveliquid monomer contained within the expandable portion duringpolymerization.

According to aspects illustrated herein, a method includes providing asystem comprising a catheter having an elongated shaft with a proximalend adapter, a distal end releasably engaging an expandable portion, anda longitudinal axis therebetween; a light-conducting fiber configured totransmit light energy to the expandable portion; a light-sensitiveliquid monomer comprising an initiator, wherein the initiator isactivated when the light-conducting fiber transmits the light energy, toinitiate polymerization of the light-sensitive liquid monomer; and acooling medium configured to control polymerization temperature, whereinthe catheter comprises an inner void sufficiently designed to pass thelight-sensitive liquid monomer into the expandable portion, and whereinthe catheter comprises an inner lumen sufficiently designed to pass thelight-conducting fiber into the expandable portion and configured tocirculate the cooling medium; inserting the expandable portion of thesystem into an intramedullary canal spanning a fracture site comprisinga plurality of fractured pieces; infusing the light-sensitive liquidmonomer into the inner void of the catheter so that the light-sensitiveliquid monomer expands the expandable portion until the fractured piecesare substantially restored to their natural positions; inserting thelight-conducting fiber into the inner lumen of the catheter so that thelight-conducting fiber resides in the expandable portion; activating thelight-conducting fiber to transmit light energy to the expandableportion to initiate in situ polymerization of the light-sensitive liquidmonomer within the expandable portion; infusing the cooling medium intothe inner lumen of the catheter to control polymerization temperature;and completing the in situ polymerization of the light-sensitive liquidmonomer to harden the expandable portion at the fracture site.

BRIEF DESCRIPTION OF THE DRAWINGS

The presently disclosed embodiments will be further explained withreference to the attached drawings, wherein like structures are referredto by like numerals throughout the several views. The drawings shown arenot necessarily to scale, with emphasis instead generally being placedupon illustrating the principles of the presently disclosed embodiments.

FIG. 1 shows a side view of an embodiment of a proximal end of aphotodynamic bone stabilization system for repairing a weakened orfractured bone according to the present disclosure. The distal endincludes an expandable portion (illustrated in an expanded position)having means for preventing shrinkage of at least a portion of theexpandable portion.

FIG. 2 shows a side view of an embodiment of a distal end of aphotodynamic bone stabilization system for repairing a weakened orfractured long bone according to the present disclosure.

FIG. 3 shows a side view of an embodiment of a distal end of aphotodynamic bone stabilization system for repairing a weakened orfractured bone according to the present disclosure. The distal endincludes an expandable portion (illustrated in an expanded position)having an internal lumen penetrating through a distal end of theexpandable portion for cooling through the length of the expandableportion.

FIG. 4 shows a side view of the expandable portion of FIG. 3 after alight-sensitive liquid has been added to the expandable portion and acuring process has been initiated. A light-conducting fiber introducedinto the inner lumen of the expandable portion is activated, while acooling medium flows through the inner lumen and out the distal end ofthe expandable portion.

FIGS. 5A-5D illustrate an embodiment of a procedure for repairing aweakened or fractured bone. FIG. 5A is a side view of an embodiment of adistal end of a photodynamic bone stabilization system for repairing aweakened or fractured bone positioned within a fractured bone. Thedistal end includes an expandable portion having an internal lumenpenetrating through a distal end of the expandable portion for coolingthrough the length of the expandable portion. The distal end of theexpandable portion releasably engages a catheter. FIG. 5B is a side viewof the expandable portion of FIG. 5A after a light-sensitive liquidmonomer has been added to the expandable portion, causing the expandableportion to inflate. FIG. 5C is a side view of the expandable portion ofFIG. 5A after a light-conducting fiber has been inserted into theexpandable portion to transmit energy to initiate a curing process. FIG.5D is a side view of the hardened expandable portion of FIG. 5Apositioned within the weakened or fractured bone after the catheter hasbeen released.

FIG. 6 shows a side view of an embodiment of a distal end of aphotodynamic bone stabilization system for repairing a weakened orfractured bone according to the present disclosure. The distal endincludes an expandable portion (illustrated in an expanded position)having an internal lumen with a return flow path for cooling.

FIG. 7 shows a side view of an embodiment of a distal end of aphotodynamic bone stabilization system for repairing a weakened orfractured bone according to the present disclosure. The distal endincludes an expandable portion (illustrated in an expanded position)having an external helical design tubing for providing cooling medium tothe expandable portion.

FIG. 8A shows a side view of an embodiment of a distal end of aphotodynamic bone stabilization system for repairing a weakened orfractured bone according to the present disclosure. The distal endincludes an expandable portion (illustrated in an expanded position)having external stiffening members.

FIG. 8B shows a sectional view of the expandable portion of FIG. 8Ataken along line B-B.

FIG. 9A shows a side view of an embodiment of a distal end of aphotodynamic bone stabilization system for repairing a weakened orfractured bone according to the present disclosure. The distal endincludes an expandable portion (illustrated in an expanded position)having external stiffening members interconnected with one another viaconnecting means.

FIG. 9B shows a sectional view of the expandable portion of FIG. 9Ataken along line B-B.

FIG. 10A shows a side view of an embodiment of a distal end of aphotodynamic bone stabilization system for repairing a weakened orfractured bone according to the present disclosure. The distal endincludes an expandable portion (illustrated in an expanded position)having internal stiffening members.

FIG. 10B shows a sectional view of the expandable portion of FIG. 10Ataken along line B-B.

FIG. 11A shows a side view of an embodiment of a distal end of aphotodynamic bone stabilization system for repairing a weakened orfractured bone according to the present disclosure. The distal endincludes an expandable portion (illustrated in an expanded position)having internal stiffening members.

FIG. 11B shows a sectional view of the balloon portion of FIG. 11A takenalong line B-B.

FIG. 12A shows a side view of an embodiment of a distal end of aphotodynamic bone stabilization system for repairing a weakened orfractured bone according to the present disclosure. The distal endincludes an expandable portion (illustrated in an expanded position)having external stiffening members that move into a corrugated shapeupon a temperature change, as well as a means for cooling the expandableportion.

FIGS. 12B-12G show cross-sectional views of various embodiments ofmetallic memory-type metal pieces for use as external or internalstiffening members for an expandable portion of a system of the presentdisclosure. FIG. 12B shows a stiffening member having a rectangularcross-section. FIG. 12C shows a stiffening member having a trapezoidcross-section. FIG. 12D shows a stiffening member having a uniquecross-section. FIG. 12E shows a stiffening member having a triangularcross-section. FIG. 12F shows a stiffening member having a bow-tiecross-section. FIG. 12G shows a stiffening member having a roundedrectangular cross-section.

While the above-identified drawings set forth presently disclosedembodiments, other embodiments are also contemplated, as noted in thediscussion. This disclosure presents illustrative embodiments by way ofrepresentation and not limitation. Numerous other modifications andembodiments can be devised by those skilled in the art which fall withinthe scope and spirit of the principles of the presently disclosedembodiments.

DETAILED DESCRIPTION

The embodiments disclosed herein relate to minimally invasive orthopedicprocedures, and more particularly to photodynamic bone stabilizationsystems for use in repairing a weakened or fractured bone. In anembodiment, a photodynamic bone stabilization system includes athin-walled, non-compliant, expandable portion releasably mounted on asmall diameter, flexible insertion catheter. In an embodiment, theexpandable portion is adapted to reside within an inner cavity of atleast two bone fragments and provide support to the bone fragments. Inan embodiment, the expandable portion is adapted to reside within aninner cavity of at least two bone fragments and secure the bonefragments in a relatively fixed relationship to each another, thusensuring that the fractured bone can regenerate in the properorientation and fuse the fracture.

In an embodiment, a photodynamic bone stabilization system of thepresent disclosure is used to treat a fracture including, but notlimited to, a hand fracture, a wrist fracture, a radius fracture, anulna fracture, a clavicle fracture, a metacarpal fracture, a phalanxfracture, a metatarsal fracture, a phalange fracture, a tibia fracture,a fibula fracture, a humerus fracture, and a rib fracture. Long bonesare the large bones in the arms and legs, and include the humerus, theradius/ulna, the femur and the tibia/fibula. In an embodiment, aphotodynamic bone stabilization system of the present disclosure is usedto reinforce a fractured long bone. In an embodiment, a photodynamicbone stabilization system of the present disclosure is used to stabilizea fractured long bone in conjunction with anatomic reduction (i.e.,proper reorientation of fractured elements to their original position,both relative to one another and relative to other adjacent anatomicalfeatures).

FIG. 1 shows an embodiment of a proximal end 112 of a flexible insertioncatheter 101 of a photodynamic bone stabilization system of the presentdisclosure for repairing a weakened or fractured bone. The photodynamicbone stabilization system includes a thin-walled, non-compliant,expandable portion (not visible in FIG. 1) releasably mounted at adistal end of the flexible insertion catheter 101. In an embodiment, theflexible insertion catheter 101 includes one or more radiopaque markersor bands positioned at various locations. The one or more radiopaquebands, using radiopaque materials such as barium sulfate, tantalum, orother materials known to increase radiopacity, allows a medicalprofessional to view the insertion catheter 101 using fluoroscopytechniques. A proximal end adapter 105 includes at least one arm and atleast one adapter which can be utilized for the infusion and withdrawalof fluids or as conduits for the introduction of devices (e.g., alight-conducting fiber). In an embodiment, an adapter is a Luer lock. Inan embodiment, an adapter is a Tuohy-Borst connector. In an embodiment,an adapter is a multi-functional adapter. FIG. 1 shows a side view of athree arm proximal end fitting having three adapters 115, 125, and 135.Adapter 115 can accept, for example, a light-conducting fiber. Adapter125 can accept, for example, air or fluid. In an embodiment, adapter 125can accept, for example, a cooling medium. In an embodiment, adapter 125can accept, for example, pressurizing medium. Adapter 135 can accept,for example, a syringe housing a light-sensitive liquid. In anembodiment, the light-sensitive liquid is a liquid monomer comprising aninitiator, wherein the initiator is activated when the light-conductingfiber transmits light energy. In an embodiment, the viscosity of thelight-sensitive liquid is about 1000 cP or less. In an embodiment, thelight-sensitive liquid has a viscosity ranging from about 650 cP toabout 450 cP. Low viscosity allows filling of the expandable portionthrough a very small delivery system.

In an embodiment, a syringe housing light-sensitive liquid is attachedto the adapter 135 at the proximal end 112 of the insertion catheter101, and during use of the photodynamic bone stabilization system, thesyringe plunger is pushed, allowing the syringe to expel thelight-sensitive liquid into an inner void 110 (not visible in FIG. 1) ofthe photodynamic bone stabilization system. As the light-sensitiveliquid is expelled through the inner void, it reaches the expandableportion to move the expandable portion from a deflated state to aninflated state. The light-sensitive liquid can be aspirated andreinfused as necessary, allowing for adjustments to the expandableportion prior to curing of the light-sensitive liquid, wherein curing ofthe light-sensitive liquid hardens the expandable portion in a desiredposition to stabilize the fracture. These properties allow a user toachieve maximum fracture reduction prior to activating a light sourceand converting the liquid monomer into a hard polymer.

In an embodiment, a light-conducting fiber communicating light from alight source is introduced into adapter 115 at the proximal end 112 ofthe insertion catheter 101 to pass the light-conducting fiber within aninner lumen 120 (not visible in FIG. 1) of the photodynamic bonestabilization system. In an embodiment, the light-conducting fiber is anoptical fiber. Optical fibers may be used in accordance with the presentdisclosure to communicate light from the light source to the remotelocation. Optical fibers use a construction of concentric layers foroptical and mechanical advantages. The most basic function of a fiber isto guide light, i.e., to keep light concentrated over longer propagationdistances—despite the natural tendency of light beams to diverge, andpossibly even under conditions of strong bending. In the simple case ofa step-index fiber, this guidance is achieved by creating a region withincreased refractive index around the fiber axis, called the fiber core,which is surrounded by the cladding. The cladding is usually protectedwith at least a polymer coating. Light is kept in the “core” of theoptical fiber by total internal reflection. Cladding keeps lighttraveling down the length of the fiber to a destination. In someinstances, it is desirable to conduct electromagnetic waves along asingle guide and extract light along a given length of the guide'sdistal end rather than only at the guide's terminating face. In someembodiments of the present disclosure, at least a portion of a length ofan optical fiber is modified, e.g., by removing the cladding, in orderto alter the direction, propagation, amount, intensity, angle ofincidence, uniformity and/or distribution of light.

The optical fiber can be made from any material, such as glass, silicon,silica glass, quartz, sapphire, plastic, combinations of materials, orany other material, and may have any diameter, as not all embodiments ofthe present disclosure are intended to be limited in this respect. In anembodiment, the optical fiber is made from a polymethyl methacrylatecore with a transparent polymer cladding. The optical fiber can have adiameter between approximately 0.75 mm and approximately 2.0 mm. In someembodiments, the optical fiber can have a diameter of about 0.75 mm,about 1 mm, about 1.5 mm, about 2 mm, less than about 0.75 mm or greaterthan about 2 mm as not all embodiments of the present disclosure areintended to be limited in this respect. In an embodiment, the opticalfiber is made from a polymethyl methacrylate core with a transparentpolymer cladding. It should be appreciated that the above-describedcharacteristics and properties of the optical fibers are exemplary andnot all embodiments of the present disclosure are intended to be limitedin these respects. Light energy from a visible emitting light source canbe transmitted by the optical fiber. In an embodiment, visible lighthaving a wavelength spectrum of between about 380 nm to about 780 nm,between about 400 nm to about 600 nm, between about 420 nm to about 500nm, between about 430 nm to about 440 nm, is used to cure thelight-sensitive liquid.

The light-sensitive liquid remains a liquid monomer until activated bythe light-conducting fiber (cures on demand). Radiant energy from thelight-conducting fiber is absorbed and converted to chemical energy toquickly polymerize the monomer. This cure affixes the expandable portionin an expanded shape. A cure may refer to any chemical, physical, and/ormechanical transformation that allows a composition to progress from aform (e.g., flowable form) that allows it to be delivered through theinner void in the insertion catheter 101, into a more permanent (e.g.,cured) form for final use in vivo. For example, “curable” may refer touncured composition, having the potential to be cured in vivo (as bycatalysis or the application of a suitable energy source), as well as toa composition in the process of curing (e.g., a composition formed atthe time of delivery by the concurrent mixing of a plurality ofcomposition components).

The presently disclosed embodiments provide expandable portions ofphotodynamic bone stabilization systems of the present disclosure. Itshould be understood that any of the expandable portions disclosedherein may include one or more radiopaque markers or bands. For example,a radiopaque ink bead may be placed at a distal end of the expandableportion for alignment of the system during fluoroscopy. The one or moreradiopaque bands and radiopaque ink bead, using radiopaque materialssuch as barium sulfate, tantalum, or other materials known to increaseradiopacity, allows a medical professional to view the expandableportion during positioning to properly position the expandable during arepair procedure, and allows the medical professional to view theexpandable portion during inflation and/or deflation to properlystabilize and align the fractured bones. In an embodiment, the one ormore radiopaque bands permit visualization of any voids that may becreated by air that gets entrapped in the expandable portion. In anembodiment, the one or more radiopaque bands permit visualization topreclude the expandable portion from misengaging or not meeting a bonedue to improper inflation to maintain a uniform expandable/boneinterface.

It should be understood that any of the expandable portions disclosedherein may be round, flat, cylindrical, oval, rectangular or any desiredshape for a given application. The expandable portion may be formed of apliable, resilient, conformable, and strong material, including but notlimited to urethane, polyethylene terephthalate (PET), nylon elastomerand other similar polymers. In an embodiment, the expandable portion isconstructed out of a PET nylon aramet or other non-consumable materials.In an embodiment, the expandable portion may be formed from a materialthat allows the expandable portion to conform to obstructions or curvesat the site of implantation.

It should be understood that any of the expandable portions disclosedherein by way of example, but not of limitation, can have the followingdimensions: In an embodiment, the expandable portion has a diameterranging from about 5 mm to about 20 mm. In an embodiment, the expandableportion has a length ranging from about 20 mm to about 450 mm. In anembodiment, the expandable portion has a diameter of about 5 mm and alength of about 30 mm. In an embodiment, the expandable portion has adiameter of about 5 mm and a length of about 40 mm. In an embodiment,the expandable portion has a diameter of about 6 mm and a length ofabout 30 mm. In an embodiment, the expandable portion has a diameter ofabout 6 mm and a length of about 40 mm. In an embodiment, the expandableportion has a diameter of about 6 mm and a length of about 50 mm. In anembodiment, the expandable portion has a diameter of about 7 mm and alength of about 30 mm. In an embodiment, the expandable portion has adiameter of about 7 mm and a length of about 40 mm. In an embodiment,the expandable portion has a diameter of about 7 mm and a length ofabout 50 mm. In an embodiment, the expandable portion has a diameter ofabout 14 mm and a length of about 400 mm. In an embodiment, theexpandable portion has a diameter of about 14 mm and a length of about300 mm.

It should be understood that any of the expandable portions disclosedherein includes an outer surface that, in an embodiment, may be coatedwith materials or additives such as drugs, bone glue, proteins, growthfactors, or other natural or synthetic coatings (for example, radiopaqueor ultrasonically active materials). For example, after a minimallyinvasive surgical procedure an infection may develop in a patient,requiring the patient to undergo antibiotic treatment. An antibioticdrug may be added to the outer surface of the expandable portion toprevent or combat a possible infection. Proteins, such as, for example,bone morphogenic protein or other growth factors have been shown toinduce the formation of cartilage and bone. A growth factor may be addedto the outer surface of the expandable portion to help induce theformation of new bone. Due to the lack of thermal egress of thelight-sensitive liquid in the expandable portion, the effectiveness andstability of the coating is maintained.

It should be understood that the expandable portions disclosed hereintypically do not have any valves. One benefit of having no valves isthat the expandable portion may be inflated or deflated as much asnecessary to assist in the fracture reduction and placement. Anotherbenefit of the expandable portion having no valves is the efficacy andsafety of the system. Since there is no communication passage oflight-sensitive liquid to the body there cannot be any leakage of liquidbecause all the liquid is contained within the expandable portion. In anembodiment, a permanent seal is created between the expandable portionthat is both hardened and affixed prior to the insertion catheter beingremoved. The expandable portion may have valves, as all of theembodiments are not intended to be limited in this manner.

It should be understood that the expandable portions disclosed hereininclude an outer surface that is resilient and puncture resistant. In anembodiment, the outer surface of the expandable portion is substantiallyeven and smooth. In an embodiment, the outer surface of the expandableportion is not entirely smooth and may have some small bumps orconvexity/concavity along the length. In an embodiment, the outersurface of the expandable portion may have ribs, ridges, bumps or othershapes. In an embodiment, the expandable portion has a textured surfacewhich provides one or more ridges that allow grabbing. In an embodiment,abrasively treating the outer surface of the expandable portion viachemical etching or air propelled abrasive media improves the connectionand adhesion between the outer surface of the expandable portion and thebone. The surfacing significantly increases the amount of surface areathat comes in contact with the bone resulting in a stronger grip.

One possible side effect of curing a light-sensitive liquid ispolymerization shrinkage. The presently disclosed embodiments providephotodynamic bone stabilization systems sufficiently designed to controlpolymerization shrinkage that may occur in an expandable portion of thesystem during use. FIG. 2 shows a side view of an embodiment of a distalend 114 of the insertion catheter 101 of FIG. 1 of a photodynamic bonestabilization system of the present sufficiently designed to controlpolymerization shrinkage during use. The photodynamic bone stabilizationsystem includes the flexible insertion catheter 101; an expandableportion 200 releasably engaging the distal end 114 of the insertioncatheter 101, the expandable portion 200 sufficiently designed to movefrom a deflated state to an inflated state; and at least two portslocated at the proximal end 112 of the insertion catheter 101, the portssufficiently designed to attach with various co-components of thephotodynamic bone stabilization system, including, but not limited to, acontainer or syringe for delivering a light-sensitive liquid through theinsertion catheter 101 and up into the expandable portion 200, alight-conducting fiber for delivering light energy to expandable portion200, and a syringe or hose for delivering air or other fluids to theexpandable portion 200 to substantially prevent polymerizationshrinkage.

The inner lumen 120 passes through the longitudinal axis of the flexibleinsertion catheter 101 and the expandable portion 200. The inner lumen120 is sufficiently designed to pass a light-conducting fiber. The innervoid 110 exists between an outer surface of the inner lumen 120 and aninner surface 130 of the insertion catheter 101; and an outer surface ofthe inner lumen 120 and an inner surface 230 of the expandable portion200 and provides a passageway for light-sensitive liquid to travel.

During a procedure for repairing a weakened to fractured long bone, theexpandable portion 200 is positioned between bone fragments andlight-sensitive liquid is passed through the inner void 110 of thephotodynamic bone stabilization system until it reaches the expandableportion 200 and begins to expand or inflate the expandable portion 200.The expandable portion 200 is inflated in situ with light-sensitiveliquid to stabilize and reduce the fracture, which can optionally beperformed under fluoroscopy. Because the light-sensitive liquid will notcure until illumination with light from the light-conducting fiber, theexpandable portion 200 can be inflated and deflated as many times asneeded in situ to insure the proper stabilization and reduction of thefracture. Once proper positioning of the expandable portion 200 isdetermined, the light-conducting fiber is positioned in the inner lumen120 of the photodynamic bone stabilization system and activated, todeliver output energy to the expandable portion 200 which willpolymerize or cure the light-sensitive liquid. There is the potentialthat during in situ curing of the light-sensitive liquid, areas of theexpandable portion 200 that are not in the immediate vicinity of thepolymerization process may exhibit polymerization shrinkage upon cure ofabout 2 to about 3 percent. This may be especially relevant when theexpandable portion 200 is used to reduce and stabilize a long bone,where the expandable portion 200 may have a diameter ranging from about13 mm to about 20 mm and a length ranging from about 100 mm to about 450mm. To prevent shrinkage from occurring, the inner lumen 120 in theexpandable portion 200 can be pressurized by virtue of the infusion ofeither air or other fluids (e.g., saline or water) to cause internaldiameter pressure against the light-sensitive liquid contained withinthe expandable portion 200 so that during the curing, the pressure keepsthe light-sensitive liquid pressurized, and up in contact with innerwalls 230 of the expandable portion 200. In some embodiments, the innerlumen 120 in the expandable portion 200 is configured to include areas224 which are capable of expanding when pressurized with air or otherfluids.

In an embodiment, the inner lumen 120 in the expandable portion 200includes one area 224 configured to prevent the effects ofpolymerization shrinkage during curing of the light-sensitive liquid. Inan embodiment, the inner lumen 120 in the expandable portion 200includes two areas 224 configured to prevent the effects ofpolymerization shrinkage during curing of the light-sensitive liquid. Asillustrated in FIG. 2, the inner lumen 120 in the expandable portion 200includes five areas 224 configured to prevent the effects ofpolymerization shrinkage during curing of the light-sensitive liquid.Depending on the length and the diameter of the expandable portion 200used for a particular procedure, it is possible to determine how manyareas 224 are required to prevent the effects of polymerizationshrinkage during curing of the light-sensitive liquid.

One possible side effect of curing a light-sensitive liquid besidespolymerization shrinkage is temperature rise. The temperature rise is indirect relation with the strength of polymerization light intensity. Forinstance, as intensity grows, so does the temperature. The presentlydisclosed embodiments provide photodynamic bone stabilization systemssufficiently designed to control temperature rise that may occur in anexpandable portion of the system during use. In an embodiment, thephotodynamic bone stabilization systems include an expandable portionsufficiently designed to move from a deflated state to an inflated statewhen a light-sensitive liquid is delivered to the expandable portion.Once proper positioning and expansion of the expandable portion isdetermined, the light-sensitive liquid can be cured in situ to hardenthe expandable portion thus providing a rigid orthopedic stabilizer.During use, there is the potential that the in situ curing process ofthe light-sensitive liquid can cause one or more areas of the expandableportion to experience a temperature rise. To prevent a temperature risefrom occurring, a cooling medium can be delivered so as to cool theexpandable portion during the curing process. Cooling medium for usewith a photodynamic bone stabilization system of the present disclosureincludes, but is not limited to, gases, liquids and combinationsthereof. Examples of gases include, but are not limited to, inert gasesand air. Examples of liquids include, but are not limited to, water,saline, saline-ice mixtures, liquid cryogen. In an embodiment, thecooling medium is water. The cooling medium can be delivered to theexpandable portion at room temperature or at a cooled temperature. In anembodiment, the cooling medium improves the numerical aperture betweenthat of the light-conducting fiber and the inner lumen for thelight-conducting fiber because it is desirable to take up the airbetween the light-conducting fiber and the material of the expandableportion so as to improve light transmission. Therefore, the lighttransmission will be light-conducting fiber-cooling media-expandableportion-light-sensitive liquid as opposed to light-conductingfiber-air-expandable portion-light-sensitive liquid. In an embodiment,the cooling medium transmitted through the inner lumen takes awayextraneous heat.

FIG. 3 shows a side view of an embodiment of a distal end 114 of theinsertion catheter 101 of FIG. 1 of a photodynamic bone stabilizationsystem of the present disclosure sufficiently designed to controltemperature rise during use. The photodynamic bone stabilization systemincludes the flexible insertion catheter 101; an expandable portion 300releasably engaging the distal end 114 of the insertion catheter 101,the expandable portion 300 sufficiently designed to move from a deflatedstate to an inflated state; and at least two ports located at theproximal end 112 of the insertion catheter 101, the ports sufficientlydesigned to attach with various co-components of the photodynamic bonestabilization system, including, but not limited to, a container orsyringe for delivering a light-sensitive liquid through the insertioncatheter 101 and up into the expandable portion 300, a light-conductingfiber for delivering light energy to expandable portion 300, and asyringe or hose for delivering cooling medium to the expandable portion300.

In the embodiment illustrated in FIG. 3, the inner lumen 120 passesthrough the longitudinal axis of the flexible insertion catheter 101 andthrough a distal end 314 of the expandable portion 300. The inner lumen120 is sufficiently designed to pass a light-conducting fiber, and isconfigured to pass a cooling medium. The inner void 110 exists betweenan outer surface of the inner lumen 120 and an inner surface 130 of theinsertion catheter 101; and an outer surface of the inner lumen 120 andan inner surface 330 of the expandable portion 300 and provides apassageway for light-sensitive liquid to travel.

During a procedure for repairing a weakened to fractured long bone, theexpandable portion 300 is positioned between bone fragments andlight-sensitive liquid is passed through the inner void 110 of thephotodynamic bone stabilization system until it reaches the expandableportion 300 and begins to expand or inflate the expandable portion 300.The expandable portion 300 is inflated in situ with light-sensitiveliquid to stabilize and reduce the fracture, which can optionally beperformed under fluoroscopy. Because the light-sensitive liquid will notcure until illumination with light from the light-conducting fiber, theexpandable portion 300 can be inflated and deflated as many times asneeded in situ to insure the proper stabilization and reduction of thefracture. Once proper positioning of the expandable portion 300 isdetermined, the light-conducting fiber is positioned in the inner lumen120 of the photodynamic bone stabilization system and activated, todeliver output energy to the expandable portion 300 which willpolymerize or cure the light-sensitive liquid. During use, there is thepotential that the in situ curing process of the light-sensitive liquidcan cause one or more areas of the expandable portion 300 to experiencea temperature rise. To prevent a temperature rise from occurring, acooling medium can be delivered through the inner lumen 120 concurrentlywith the light-conducting fiber, so as to cool the expandable portion300 during the curing process.

FIG. 4 shows a side view of the expandable portion 300 of FIG. 3 after alight-sensitive liquid 315 has been added to the expandable portion 300.A light-conducting fiber 325 is introduced into the inner lumen 120 ofthe expandable portion 300 and activated to cure the light-sensitiveliquid, while a cooling medium 328 flows through the inner lumen 120 andout the distal end 314 of the expandable portion 300.

FIGS. 5A-5D illustrate an embodiment of a procedure for repairing aweakened or fractured bone using the photodynamic bone stabilizationsystem illustrated in FIG. 3. As illustrated in FIG. 5A, a procedure forrepairing a weakened or fractured bone includes positioning theexpandable portion 300 between bone fragments. In an embodiment, theexpandable portion 300 spans multiple bone fragments. Once theexpandable portion 300 is positioned, light-sensitive liquid monomer 315is passed through the inner void 110 of the photodynamic bonestabilization system until it reaches the expandable portion 300 andbegins to expand or inflate the expandable portion 300, as shown in FIG.5B. The expandable portion 300 is inflated in situ with light-sensitiveliquid monomer 315 to stabilize and reduce the fracture, which canoptionally be performed under fluoroscopy. Because the light-sensitiveliquid monomer 315 will not cure until illumination with light from thelight-conducting fiber 325, the expandable portion 300 can be inflatedand deflated as needed in situ to insure the proper stabilization andreduction of the fracture. Once proper positioning of the expandableportion 300 is determined, the light-conducting fiber 325 is introducedinto the inner lumen 120 of the expandable portion 300 and activated, todeliver output energy to the expandable portion 300 which willpolymerize or cure the light-sensitive liquid monomer, as shown in FIG.5C. During use, there is the potential that the in situ curing processof the light-sensitive liquid monomer 315 can cause one or more areas ofthe expandable portion 300 to experience a temperature rise. Asillustrated in FIG. 5C, to prevent a temperature rise from occurring, acooling medium can be delivered through the lumen 120 of the expandableportion 300 to cool the expandable portion 300 during the curingprocess. In an embodiment, the cooling medium exits out the distal end314 of the expandable portion 300 and collects or accumulates within thebone after exiting the expandable portion 300. FIG. 5D shows thehardened expandable portion 300 positioned within the weakened orfractured bone after the catheter 101 has been released.

FIG. 6 shows a side view of an embodiment of a distal end 114 of theinsertion catheter 101 of FIG. 1 of a photodynamic bone stabilizationsystem of the present disclosure sufficiently designed to controltemperature rise during use. The photodynamic bone stabilization systemincludes the flexible insertion catheter 101; an expandable portion 500releasably engaging the distal end 114 of the insertion catheter 101,the expandable portion 500 sufficiently designed to move from a deflatedstate to an inflated state; and at least two ports located at theproximal end 112 of the insertion catheter 101, the ports sufficientlydesigned to attach with various co-components of the photodynamic bonestabilization system, including, but not limited to, a container orsyringe for delivering a light-sensitive liquid through the insertioncatheter 101 and up into the expandable portion 500, a light-conductingfiber for delivering light energy to expandable portion 500, and asyringe or hose for delivering cooling medium to the expandable portion300.

In the embodiment illustrated in FIG. 6, the inner lumen 120 passesthrough the longitudinal axis of the flexible insertion catheter 101into the expandable portion 500. In an embodiment, the inner lumen 120comprises a septum lumen 130 for passing the light-conducting fiber, theseptum lumen 130 sufficiently designed to divide the inner lumen 120into a cooling medium intake lumen 122 communicating with a coolinginlet and a cooling medium return lumen 124 communicating with a coolingoutlet. In an embodiment, the inner lumen 120 is a return flow path forthe cooling medium. The inner void 110 exists between an outer surfaceof the inner lumen 120 and an inner surface 530 of the insertioncatheter 101; and an outer surface of the inner lumen 120 and an innersurface 530 of the expandable portion 500 and provides a passageway forlight-sensitive liquid to travel.

During a procedure for repairing a weakened or fractured long bone, theexpandable portion 500 is positioned between bone fragments andlight-sensitive liquid is passed through the inner void 110 of thephotodynamic bone stabilization system until it reaches the expandableportion 500 and begins to expand or inflate the expandable portion 500.The expandable portion 500 is inflated in situ with light-sensitiveliquid to stabilize and reduce the fracture, which can optionally beperformed under fluoroscopy. Because the light-sensitive liquid will notcure until illumination with light from the light-conducting fiber, theexpandable portion 500 can be inflated and deflated as many times asneeded in situ to insure the proper stabilization and reduction of thefracture. Once proper positioning of the expandable portion 500 isdetermined, the light-conducting fiber is positioned in the septum lumen130 of the photodynamic bone stabilization system and activated, todeliver output energy to the expandable portion 500 which willpolymerize or cure the light-sensitive liquid. During use, there is thepotential that the in situ curing process of the light-sensitive liquidcan cause one or more areas of the expandable portion 500 to experiencea temperature rise. To prevent a temperature rise from occurring, acooling medium can be delivered through the cooling medium intake lumen122 so as to cool the expandable portion 500 during the curing process.The cooling medium is removed from the photodynamic bone stabilizationsystem via the cooling medium return lumen 124.

FIG. 7 shows a side view of an embodiment of a distal end 114 of theinsertion catheter 101 of FIG. 1 of a photodynamic bone stabilizationsystem of the present disclosure sufficiently designed to controltemperature rise during use. The photodynamic bone stabilization systemincludes the flexible insertion catheter 101; an expandable portion 600releasably engaging the distal end 114 of the insertion catheter 101,the expandable portion 600 sufficiently designed to move from a deflatedstate to an inflated state; and at least two ports located at theproximal end 112 of the insertion catheter 101, the ports sufficientlydesigned to attach with various co-components of the photodynamic bonestabilization system, including, but not limited to, a container orsyringe for delivering a light-sensitive liquid through the insertioncatheter 101 and up into the expandable portion 600, a light-conductingfiber for delivering light energy to expandable portion 600, and asyringe or hose for delivering cooling medium to the expandable portion600.

In the embodiment illustrated in FIG. 7, the inner lumen 120 (notvisible in FIG. 7) passes through the longitudinal axis of the flexibleinsertion catheter 101 and into the expandable portion 600. The innerlumen 120 is sufficiently designed to pass a light-conducting fiber. Theinner void 110 (not visible in FIG. 7) exists between an outer surfaceof the inner lumen 120 and an inner surface 130 (not visible in FIG. 7)of the insertion catheter 101; and an outer surface of the inner lumen120 and an inner surface 630 (not visible in FIG. 7) of the expandableportion 600 and provides a passageway for light-sensitive liquid totravel. The expandable portion 600 includes external helical tubing 680for providing cooling medium to the expandable portion 600.

During a procedure for repairing a weakened to fractured long bone, theexpandable portion 600 is positioned between bone fragments andlight-sensitive liquid is passed through the inner void 110 of thephotodynamic bone stabilization system until it reaches the expandableportion 600 and begins to expand or inflate the expandable portion 600.The expandable portion 600 is inflated in situ with light-sensitiveliquid to stabilize and reduce the fracture, which can optionally beperformed under fluoroscopy. Because the light-sensitive liquid will notcure until illumination with light from the light-conducting fiber, theexpandable portion 600 can be inflated and deflated as many times asneeded in situ to insure the proper stabilization and reduction of thefracture. Once proper positioning of the expandable portion 600 isdetermined, the light-conducting fiber is positioned in the inner lumen120 of the photodynamic bone stabilization system and activated, todeliver output energy to the expandable portion 600 which willpolymerize or cure the light-sensitive liquid. During use, there is thepotential that the in situ curing process of the light-sensitive liquidcan cause one or more areas of the expandable portion 600 to experiencea temperature rise. To prevent a temperature rise from occurring, acooling medium can be delivered through the external helical tubing 680so as to cool the expandable portion 600 from the outside during thecuring process.

In an embodiment, a method for repairing a fractured bone in a patientusing a photodynamic bone stabilization system sufficiently designed tocontrol temperature rise that may occur during use includes: a minimallyinvasive incision is made through a skin of the patient to expose thefractured bone. The incision may be made at the proximal end or thedistal end of the fractured bone to expose a bone surface. Once the bonesurface is exposed, it may be necessary to retract some muscles andtissues that may be in view of the fractured bone. At least a firstproximal access hole is formed in the fractured bone by drilling orother methods known in the art. The first proximal access hole extendsthrough a hard compact outer layer of the fractured bone into therelatively porous inner or cancellous tissue. For bones with marrow, themedullary material should be cleared from the medullary cavity prior toinsertion of the insertion catheter. Marrow is found mainly in the flatbones such as hip bone, breast bone, skull, ribs, vertebrae and shoulderblades, and in the cancellous material at the proximal ends of the longbones like the femur and humerus. Once the medullary cavity is reached,the medullary material including air, blood, fluids, fat, marrow, tissueand bone debris should be removed to form a void. The void is defined asa hollowed out space, wherein a first position defines the most distaledge of the void with relation to the penetration point on the bone, anda second position defines the most proximal edge of the void withrelation to the penetration site on the bone. The bone may be hollowedout sufficiently to have the medullary material of the medullary cavityup to the cortical bone removed. In an embodiment, such as when theexpandable portion 300 of FIG. 3 is used, a second distal access hole isformed in the fractured bone. The second distal access hole is createdsuch that the cooling medium pooling out of the distal end 314 of theexpandable portion 300 can be collected. An introducer sheath may beintroduced into the bone via the first access hole and placed betweenbone fragments of the bone to cross the location of a fracture. Theintroducer sheath may be delivered into the lumen of the bone andcrosses the location of the break so that the introducer sheath spansmultiple sections of bone fragments. The expandable portion of theinsertion catheter, is delivered through the introducer sheath to thesite of the fracture and spans the bone fragments of the bone. Once theexpandable portion is in place, the guidewire may be removed. Thelocation of the expandable portion may be determined using at least oneradiopaque marker which is detectable from the outside or the inside ofthe bone. Once the expandable portion is in the correct position withinthe fractured bone, the introducer sheath may be removed. A deliverysystem housing a light-sensitive liquid is attached to the proximal endof the insertion catheter. The light-sensitive liquid is then infusedthrough an inner void in the insertion catheter and enters theexpandable portion. This addition of the light-sensitive liquid withinthe expandable portion causes the expandable portion to expand. As theexpandable portion is expanded, the fracture is reduced.

Once orientation of the bone fragments are confirmed to be in a desiredposition, the light-sensitive liquid may be cured within the expandableportion, such as by illumination with a visible emitting light source.In an embodiment, visible light having a wavelength spectrum of betweenabout 380 nm to about 780 nm, between about 400 nm to about 600 nm,between about 420 nm to about 500 nm, between about 430 nm to about 440nm, is used to cure the light-sensitive liquid. In an embodiment, theaddition of the light causes the photoinitiator in the light-sensitiveliquid, to initiate the polymerization process: monomers and oligomersjoin together to form a durable biocompatible crosslinked polymer. In anembodiment, the cure provides complete 360 degree radial andlongitudinal support and stabilization to the fractured bone. Duringthis curing, a syringe housing the cooling medium is attached to theproximal end of the insertion catheter and continuously delivered to theexpandable portion. When the expandable portion 300 of FIG. 3 is used,the cooling medium can be collected by connecting tubing to the distalend 314 of the expandable portion 300 and collecting the cooling mediumvia the second distal access hole. After the light-sensitive liquid hasbeen hardened, the light-conducting fiber can be removed from theinsertion catheter. The expandable portion once hardened, may bereleased from the insertion catheter. The hardened expandable portionremains in the fractured bone, and the insertion catheter is removed. Inan embodiment, the outer surface of the hardened expandable portionmakes contact with the cortical bone.

In an embodiment, a photodynamic bone stabilization system of thepresent disclosure is sufficiently designed to selectively stiffen anexpandable portion of the system during use. In an embodiment, aphotodynamic bone stabilization system of the present disclosureincludes an expandable portion having a plurality of stiffening members.In an embodiment, the plurality of stiffening members are disposed alongthe length of the expandable portion. In an embodiment, the plurality ofstiffening members are disposed along the length of an outer surface ofthe expandable portion. In an embodiment, the plurality of stiffeningmembers are disposed along the length of an inner surface of theexpandable portion. The stiffening members can be secured to theexpandable portion in a variety of ways. For example and not limitation,the stiffening members can be secured to an adapter, e.g., luer, hub,manifold, or a reinforcement or filler material, or support member.Alternatively, the stiffening members can be secured to the expandableportion by way of an engagement member. In this manner, an engagementmember can be secured to the surface of the expandable portion such thata space or cavity is defined for engaging the stiffening members. In anembodiment, the expandable portion includes a plurality of stiffeningmembers configured to control or vary axial flexibility along a lengthof the expandable portion. In an embodiment, the expandable portionincludes a plurality of stiffening members that can be disposed radiallyand/or axially.

FIG. 8A, FIG. 8B, FIG. 9A, FIG. 9B, FIG. 10A, FIG. 10B, FIG. 11A, FIG.11B, and FIG. 12A show various embodiments of a distal end 114 of theinsertion catheter 101 of FIG. 1 of a photodynamic bone stabilizationsystem of the present disclosure sufficiently designed to control orvary axial flexibility along a length of the expandable portion. In suchembodiments, a stiffness of the expandable portion has been increaseddue to the presence of an external stiffening member(s) (see FIG. 8A,FIG. 8B, FIG. 9A, FIG. 9B and FIG. 12A) or an internal stiffeningmember(s) (see FIG. 10A, FIG. 10B, FIG. 11A and FIG. 11B). In anembodiment, the expandable portion includes internal stiffeningmember(s). In an embodiment, the expandable portion includes externalstiffening member(s). In an embodiment, the expandable portion includesa combination of internal stiffening member(s) and external stiffeningmember(s). In an embodiment, external and internal stiffening member(s)can be made from metal materials such as, for example, Nitonol ormetallic memory-type metal pieces. In an embodiment, the stiffeningmember(s) or metallic pieces may be of any size or geometric shapedesirable.

In an embodiment, the stiffening members or metallic pieces may protrudeor extend from the expandable portion such that the metallic piecesextend beyond the diameter of the expandable portion. In an embodiment,stiffening members or metallic pieces may be situated within theexpandable portion such that the diameter of the expandable portion maybe substantially maintained. In an embodiment, stiffening members ormetallic pieces may be integral with the expandable portion such thatthe expandable portion and the stiffening members are contiguous withone another. In an embodiment, stiffening members or metallic pieces maybe attached, coupled, covered, sheathed, or otherwise connected to theexpandable portion. In an embodiment, the stiffening members or metallicpieces may be contiguous with one another so as to form one structurearound the expandable portion. In an embodiment, the stiffening membersor metallic pieces can be separate and distinct so as to form multiplestructures around the expandable portion. In an embodiment, thestiffening members or metallic pieces are circumferentially connected toone another at a distal end and a proximal end forming end plates. In anembodiment, the end plates help maintain the structure of the stiffeningmembers or metallic pieces when the expandable portion is expanded.

In an embodiment, the stiffening members or metallic pieces may alter orchange their configuration under a temperature change. In an embodiment,the metallic pieces expand outwards against the bone at the site offracture. In an embodiment, the metallic pieces can expand to increasethe strength of the hardened expandable portion. In an embodiment, themetallic pieces can contract to increase the strength of the hardenedexpandable portion. In an embodiment, an inner surface of the metallicpieces (those surfaces that are in contact with the externalcircumferential surface of the expandable portion) are polished toincrease internal reflection of the light from the light-conductingfiber. In an embodiment, the metallic pieces are sufficiently designedto be load-bearing shapes. In an embodiment, the metallic pieces have alow profile and can handle large loads. In an embodiment, the metallicpieces may produce a greater amount of force on a large area than asmall area. In an embodiment, the metallic pieces may produce a greateramount of force in a tight or narrow space that in a shallow or openspace.

As illustrated in the embodiments of FIG. 8A and FIG. 8B and FIG. 9A andFIG. 9B, metallic pieces 750 and 850, respectively, are positioned onthe external circumferential surface of an expandable portion 700 and800, respectively. The metallic pieces 750 and 850 can be aligned in alongitudinal fashion, circumferentially around the expandable portion700 (FIG. 8A and FIG. 8B) and can be interconnected with one another viaconnecting means 860 such as wires (FIG. 9A and FIG. 9B). The wires 860will help hold the longitudinal metallic pieces 850 in position. Thenumber and placement of the wires 860 can vary depending on a desiredoutcome. In an embodiment, the metallic pieces expand to increase thestrength of the hardened expandable portion. In an embodiment, themetallic pieces contract to increase the strength of the hardenedexpandable portion. In an embodiment, metallic pieces 950 are positionedon an internal circumferential surface of an expandable portion 900(FIG. 10A and FIG. 10B).

In an embodiment, two metallic memory-type metal wires 1050, such asnitonol, are positioned within the expandable portion 500 from FIG. 6(FIG. 11A and FIG. 11B). Heat from a light-conducting fiber makes themetal wires 1050 get smaller, tensioning the hardened expandable portion500. In an embodiment, an expandable portion 1100 is wrapped with aplurality of flat metallic plates 1150 that move into a corrugated orother shape upon a temperature change to increase the strength of thepreviously flat metal plate 1150 into a shape capable of handling a load(FIG. 12A). In an embodiment, the metals are rectangular, semicircular,hexagonal, or triangular in section, although not all embodiments arelimited to these shapes (FIGS. 12B-12G).

The present disclosure provides photodynamic bone stabilization systemsand methods for reinforcing bone. In an embodiment, a photodynamic bonestabilization system of the present disclosure is sufficiently designedto control polymerization shrinkage that may occur in an expandableportion of the system during use. In an embodiment, a photodynamic bonestabilization system of the present disclosure is sufficiently designedto control temperature rise that may occur in an expandable portion ofthe system during use. In an embodiment, a photodynamic bonestabilization system of the present disclosure is sufficiently designedto selectively stiffen an expandable portion of the system during use.It should be understood that the benefits provided by each of thephotodynamic bone stabilization systems disclosed herein, includingmeans to control polymerization shrinkage, means to control temperaturerise, and means to selectively stiffen, can be used alone orcombination. For example, in an embodiment, a photodynamic bonestabilization system of the present disclosure includes means for bothcontrolling polymerization shrinkage and for controlling temperaturerise. In an embodiment, a photodynamic bone stabilization system of thepresent disclosure includes means for both controlling temperature riseand means to selectively stiffen (as disclosed FIG. 11 and FIG. 12). Inan embodiment, a photodynamic bone stabilization system of the presentdisclosure includes means for controlling polymerization shrinkage,means for controlling temperature rise, and means to selectivelystiffen.

In an embodiment, a photodynamic bone stabilization system includes aninsertion catheter having an elongated shaft with a proximal end, adistal end, and a longitudinal axis therebetween, the insertion catheterhaving an inner void for passing a light-sensitive liquid, an innerlumen for accepting a light-conducting fiber, and a pathway sufficientlydesigned for passing a cooling medium; an expandable portion releasablyengaging the distal end of the insertion catheter, the expandableportion moving from a deflated state to an inflated state when thelight-sensitive liquid is delivered to the expandable portion; andadapters releasably engaging the proximal end of the insertion catheterfor receiving the light-conducting fiber, the light-sensitive liquid,and the cooling medium.

In an embodiment, a photodynamic bone stabilization system includes aninsertion catheter having an elongated shaft with a proximal end, adistal end, and a longitudinal axis therebetween, the insertion catheterhaving an inner void for passing a light-sensitive liquid, and an innerlumen for accepting a light-conducting fiber, the inner lumensufficiently designed to be pressurized by virtue of infusion of air,fluid, or combinations thereof; an expandable portion releasablyengaging the distal end of the insertion catheter, the expandableportion moving from a deflated state to an inflated state when thelight-sensitive liquid is delivered to the expandable portion; andadapters releasably engaging the proximal end of the insertion catheterfor receiving the light-conducting fiber, the light-sensitive liquid,and the air or fluid, wherein the infusion of the air or fluid causesinternal diameter pressure against the light-sensitive liquid containedwithin the expandable portion so that during a curing process, pressurekeeps the light-sensitive liquid pressurized, and up in contact withinner walls of the expandable portion.

In an embodiment, a photodynamic bone stabilization system includes aninsertion catheter having an elongated shaft with a proximal end, adistal end, and a longitudinal axis therebetween, the insertion catheterhaving an inner void for passing a light-sensitive liquid, and an innerlumen for accepting a light-conducting fiber; an expandable portionreleasably engaging the distal end of the insertion catheter, theexpandable portion moving from a deflated state to an inflated statewhen the light-sensitive liquid is delivered to the expandable portion;stiffening members engaging the expandable portion; and adaptersreleasably engaging the proximal end of the insertion catheter forreceiving the light-conducting fiber and the light-sensitive liquid.

In an embodiment, a photodynamic bone stabilization system includes acatheter having an elongated shaft with a proximal end adapter, a distalend releasably engaging an expandable portion, and a longitudinal axistherebetween; a light-conducting fiber configured to transmit lightenergy to the expandable portion; a light-sensitive liquid monomercomprising an initiator, wherein the initiator is activated when thelight-conducting fiber transmits the light energy to initiatepolymerization of the light-sensitive liquid monomer; and a coolingmedium configured to control polymerization temperature, wherein thecatheter comprises an inner void sufficiently designed to pass thelight-sensitive liquid monomer into the expandable portion, and whereinthe catheter comprises an inner lumen sufficiently designed to pass thelight-conducting fiber into the expandable portion and configured tocirculate the cooling medium.

In an embodiment, a photodynamic bone stabilization system includes alight-conducting fiber configured to transmit light energy; alight-sensitive liquid monomer comprising an initiator, wherein theinitiator is activated when the light-conducting fiber transmits thelight energy; a pressurizing medium configured to control polymerizationshrinkage; and a catheter having an elongated shaft with a proximal endadapter, a distal end releasably engaging an expandable portion, and alongitudinal axis therebetween, wherein the catheter comprises an innervoid and an inner lumen, wherein the inner void is sufficiently designedto pass the light-sensitive liquid monomer into the expandable portion,wherein the inner lumen is sufficiently designed to pass thelight-conducting fiber into the expandable portion, and wherein theinner lumen comprises expandable portions configured to expand when thepressurizing medium is delivered to the inner lumen so as to causeinternal diameter pressure against the light-sensitive liquid monomercontained within the expandable portion during polymerization.

In an embodiment, a method includes providing a system comprising acatheter having an elongated shaft with a proximal end adapter, a distalend releasably engaging an expandable portion, and a longitudinal axistherebetween; a light-conducting fiber configured to transmit lightenergy to the expandable portion; a light-sensitive liquid monomercomprising an initiator, wherein the initiator is activated when thelight-conducting fiber transmits the light energy, to initiatepolymerization of the light-sensitive liquid monomer; and a coolingmedium configured to control polymerization temperature, wherein thecatheter comprises an inner void sufficiently designed to pass thelight-sensitive liquid monomer into the expandable portion, and whereinthe catheter comprises an inner lumen sufficiently designed to pass thelight-conducting fiber into the expandable portion and configured tocirculate the cooling medium; inserting the expandable portion of thesystem into an intramedullary canal spanning a fracture site comprisinga plurality of fractured pieces; infusing the light-sensitive liquidmonomer into the inner void of the catheter so that the light-sensitiveliquid monomer expands the expandable portion until the fractured piecesare substantially restored to their natural positions; inserting thelight-conducting fiber into the inner lumen of the catheter so that thelight-conducting fiber resides in the expandable portion; activating thelight-conducting fiber to transmit light energy to the expandableportion to initiate in situ polymerization of the light-sensitive liquidmonomer within the expandable portion; infusing the cooling medium intothe inner lumen of the catheter to control polymerization temperature;and completing the in situ polymerization of the light-sensitive liquidmonomer to harden the expandable portion at the fracture site.

All patents, patent applications, and published references cited hereinare hereby incorporated by reference in their entirety. It will beappreciated that several of the above-disclosed and other features andfunctions, or alternatives thereof, may be desirably combined into manyother different systems or application. Various presently unforeseen orunanticipated alternatives, modifications, variations, or improvementstherein may be subsequently made by those skilled in the art.

What is claimed is:
 1. A photodynamic bone stabilization systemcomprising: a catheter having an elongated shaft with a proximal endadapter, a distal end releasably engaging an expandable portion, and alongitudinal axis therebetween, the catheter comprising: an inner lumenextending longitudinally within the catheter from the proximal end intothe expandable portion at the distal end, and wherein a septum lumendivides the inner lumen into a cooling medium intake lumen and a coolingmedium return lumen; and an inner void; a light-conducting fiberconfigured to transmit light energy to the expandable portion, whereinthe light-conducting fiber is sized to pass within a longitudinal lengthof the septum lumen; a light-sensitive liquid monomer comprising aninitiator, wherein the initiator is activated when the light-conductingfiber transmits the light energy to initiate polymerization of thelight-sensitive liquid monomer; a cooling medium configured to controlpolymerization temperature, wherein the cooling medium enters the innerlumen through the cooling medium intake lumen and exits the inner lumenthrough the cooling medium return lumen; and a pressurizing mediumconfigured to control polymerization shrinkage, wherein the inner lumencomprises at least two separate areas configured to expand when thepressurizing medium is delivered to the inner lumen to cause internaldiameter pressure against the light-sensitive liquid monomer containedwithin the expandable portion during polymerization.
 2. The system ofclaim 1 wherein the proximal end adapter comprises: a first adapter forinfusion of the light-sensitive liquid; a second adapter for infusion ofthe cooling medium; and a third adapter for introduction of thelight-conducting fiber.
 3. The system of claim 1 wherein the expandableportion is fabricated from a thin-walled, non-compliant PET nylonaramet.
 4. The system of claim 1 wherein the cooling medium is one ofsaline or water.
 5. The system of claim 1 wherein the light-conductingfiber is an optical fiber configured to transmit light with a wavelengthbetween about 420 nanometers and about 500 nanometers.
 6. The system ofclaim 1 wherein at least a portion of the inner lumen is expandable whenpressurized with air or other fluids, the expandable portions configuredto prevent effects of polymerization shrinkage during curing of thelight-sensitive liquid.
 7. The system of claim 1 wherein the expandableportion includes stiffening members for selectively stiffening theexpandable portion.
 8. The system of claim 7 wherein the stiffeningmembers are positioned radially around an outside surface of theexpandable portion.
 9. The system of claim 7 wherein the stiffeningmembers are positioned radially around an inner surface of theexpandable portion.
 10. The system of claim 7 wherein the stiffeningmembers are fabricated from metallic memory-type metal piece(s).
 11. Aphotodynamic bone stabilization system comprising: a light-conductingfiber configured to transmit light energy; a light-sensitive liquidmonomer comprising an initiator, wherein the initiator is activated whenthe light-conducting fiber transmits the light energy; a pressurizingmedium configured to control polymerization shrinkage; and a catheterhaving an elongated shaft with a proximal end adapter, a distal endreleasably engaging an expandable portion, and a longitudinal axistherebetween, wherein the catheter comprises an inner void and an innerlumen, wherein the inner void is sufficiently designed to pass thelight-sensitive liquid monomer into the expandable portion, and whereinentry of the light-sensitive liquid monomer into the expandable portionmoves the expandable portion from a deflated state to an inflated state,wherein the inner lumen is sufficiently designed to pass thelight-conducting fiber into the expandable portion, and wherein theinner lumen comprises at least two separate areas configured to expandwhen the pressurizing medium is delivered to the inner lumen so as tocause internal diameter pressure against the light-sensitive liquidmonomer contained within the expandable portion during polymerization.12. The system of claim 11 further comprising: a cooling mediumconfigured to control polymerization temperature of the expandableportion.
 13. A method comprising: providing a system comprising: acatheter having an elongated shaft with a proximal end adapter, a distalend releasably engaging an expandable portion, and a longitudinal axistherebetween, the catheter comprising: an inner lumen extendinglongitudinally within the catheter into the expandable portion, whereina septum lumen divides the inner lumen into a cooling medium intakelumen and a cooling medium return lumen; and an inner void having afirst section formed along the longitudinal axis of the catheter betweenan outer surface of the inner lumen and an inner surface of theelongated shaft of the catheter and a second section formed between anouter surface of the inner lumen and an inner surface of the expandableportion; a light-conducting fiber configured to transmit light energy tothe expandable portion, wherein the light-conducting fiber is sized topass within a longitudinal length of the septum lumen; a light-sensitiveliquid monomer comprising an initiator, wherein the initiator isactivated when the light-conducting fiber transmits the light energy, toinitiate polymerization of the light-sensitive liquid monomer, andwherein the light-sensitive liquid monomer is delivered through thefirst section and the second section of the inner void into theexpandable portion to move the expandable portion from a deflated stateto an inflated state; a cooling medium configured to controlpolymerization temperature, wherein the cooling medium enters the innerlumen through the cooling medium intake lumen and exits the inner lumenthrough the cooling medium return lumen; and a pressurizing mediumconfigured to control polymerization shrinkage, wherein the inner lumencomprises at least two separate areas configured to expand when thepressurizing medium is delivered to the inner lumen to cause internaldiameter pressure against the light-sensitive liquid monomer containedwithin the expandable portion during polymerization, inserting theexpandable portion of the system into an intramedullary canal spanning afracture site comprising a plurality of fractured pieces; infusing thelight-sensitive liquid monomer into the inner void of the catheter sothat the light-sensitive liquid monomer expands the expandable portionuntil the fractured pieces are substantially restored to their naturalpositions; inserting the light-conducting fiber into the septum lumen ofthe catheter so that the light-conducting fiber resides in theexpandable portion; activating the light-conducting fiber to transmitlight energy to the expandable portion to initiate in situpolymerization of the light-sensitive liquid monomer within theexpandable portion; delivering the pressurizing medium to the innerlumen of the catheter; infusing the cooling medium into the coolingmedium intake lumen of the catheter to control polymerizationtemperature; and completing the in situ polymerization of thelight-sensitive liquid monomer to harden the expandable portion at thefracture site.
 14. The method of claim 13 further comprising removingthe light-conducting fiber from the catheter.
 15. The method of claim 13further comprising releasing the expandable portion from the catheter.16. The method of claim 13 wherein the hardened expandable portionstabilizes the fracture site.
 17. The method of claim 13 wherein thehardened expandable portion maintains the positions of the plurality offractured pieces of bone while the bone heals.
 18. The method of claim13 wherein the hardened expandable portion immobilizes joints above andbelow the fracture site.